Senior Clinical Data Science Lead

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

• As a Senior Clinical Data Science Lead at ICON, you will lead the analysis, interpretation, and management of clinical data to drive the success of our clinical trials.

What You Will Do:

You will oversee clinical data science workstreams, ensuring deliverables meet quality and timeline expectations.
Key responsibilities include:

* Responsible for leading data management activities for in-house 
and outsourced studies; 
* Responsible for vendor oversight activities across global development programs. Represents data management function on the Clinical Sub-team ensuring aligned expectations  for all data related deliverables, especially in support of key decision points and regulatory submissions. 
* Contributes influential leadership in collaboration with other stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
* Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.
* Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional 
teams.
* Leads and manages clinical trial data collection set-up, data review, and database lock:
 (a) Works with other functions to complete set up of EDC and other study data collection tools such as IRT, 
ePRO and eCOA.
 (b) Leads the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans.
 (c) Leads data review, including query management, and leads activities required for interim and final database locks.
 (d) May oversee above activities at the program level.
* Participates in preparing function for submission readiness.
* Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
* Ensures achievement of major data management deliverables and milestones in coordination with other 
functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
* Responsible for the planning and management of external Data Management budgets and timelines to ensure 
accuracy, understand trends in variances and support continuous improvement in forecasting.
* Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables 
 

Your Profile:

You will have solid clinical data science experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

*Bachelor's degree in life sciences, computer science, or a related discipline

* Preferred 6+ years of experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
* Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
* Experience with all phases of development in one or more therapeutic areas preferred.
* Ability to handle multiple development programs simultaneously.
* NDA/CTD Experience preferred.
* Strong knowledge of data management best practices & technologies as applied to clinical trials.
* Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
* Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
* Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.
* Advanced knowledge of office software (Microsoft Office).
* Experience with budget planning & management.
* Strong knowledge of relational databases and experience using multiple clinical data management systems.
* Good working knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models.
* Ensures adherence to functional budget, and provides timely updates to manager regarding additional, potential spend or cost savings.
* Expert knowledge of CDISC standards, SDTM preferred. Good experience leading standards selection and implementing in clinical trials is ideal.
* Expert knowledge of general of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.

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What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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